The HESI Cardiac Safety Committee seeks research proposals for studies involving human-relevant, mechanism-based assays evaluating cardiac safety liabilities.
In 2019, the HESI Cardiac Safety Committee was awarded a U01 grant from the U.S. FDA on the “Evaluation of Integrated Human-Relevant Approaches to Identify Drug-Induced Cardiovascular Liabilities.” This grant will support HESI in funding and managing novel, in vitro experimental studies to develop targeted mechanistic data to inform drug safety assessment for key cardiac “failure modes.”
HESI Cardiac Safety Committee members identified six main failure modes, CV liabilities contributing to drug attrition, as follows:
- Vasoactivity changes (blood pressure/heart rate)
- Inotropy changes (contractility/ejection fraction)
- Action potential changes (electrophysiology)
- Cardiomyocyte/Myocardial injury (myocardial necrosis/hypertrophy)
- Valvular injury/proliferation (regurgitant flow)
- Endothelial injury/coagulation (hemorrhage, thrombosis)
HESI is seeking proposals for a 12-month sub-award under this grant for studies involving human-relevant, mechanism-based assays evaluating cardiac safety liabilities. Interested applicants are required to first submit a Letter of Intent detailing scientific merit and study feasibility. Letters of Intent are due 8 June 2020.